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Glycophos
Published
Product name
Glycophos
Active ingredient
Sodium glycerophosphate (as hydrate)
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Glycophos (sodium glycerophosphate (as hydrate)) was approved for the following therapeutic use:
Glycophos is indicated in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.
How this medicine works
Sodium glycerophosphate is an organic phosphate salt. Glycerophosphate is a metabolic intermediate in fat metabolism. It is used as a supplement to parenteral nutrition to meet the daily requirements of phosphate.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Glycophos was considered favourable for the therapeutic use approved.
Sponsor